| Co-primary end-points |
| Comparison of Foster® versus formoterol alone in terms of: |
| COPD exacerbation rate |
| Change in pre-dose morning FEV1 from baseline to week 12 |
| Secondary end-points |
| Change from baseline in morning pre-dose and 2-h post-dose FEV1 and FVC at all clinic visits |
| Change from baseline to the average pre-dose FEV1 over the treatment period |
| Change from pre-dose to 2-h post-dose FEV1 and FVC at all clinic visits |
| Pre-dose and 2-h post-dose FEV1/FVC |
| Time to first COPD exacerbation |
| Change from baseline to the end of treatment in the SGRQ total and component scores |
| Change from baseline to the entire treatment period and to each inter-visit period in the percentage of rescue use-free days and in the average use of rescue medication (number of puffs per day) |
| Exploratory end-points |
| Change from baseline to the entire randomised treatment period and to each inter-visit period in the EXACT-PRO total score and subscale scores |
| Safety end-points |
| Adverse events |
| Adverse drug reactions |
| Vital signs |
| Haematology and blood biochemistry, including potassium and glucose |
FORWARD: Foster 48-week Trial to Reduce Exacerbations in COPD; COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; SGRQ: St George’s Respiratory Questionnaire; EXACT: Exacerbations of Chronic Pulmonary Disease Tool; PRO: patient-recorded outcome.